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Non‐Biological Complex Drugs

News

Impax announces FDA approval of follow-on sevelamer carbonate posted 17/11/2017

US generics maker Impax Laboratories (Impax) announced on 23 October 2017 that it had received final US Food and Drug Adminis...

Research

Is the EU ready for non-biological complex drug products? posted 26/05/2017

The definition of non-biological complex drugs (NBCDs) is not officially recognized, and there is no corresponding term, in t...

Guidelines

US guidelines for follow-on NBCDs posted 29/07/2016

The regulatory body for approval of medicines in the US is the Food and Drug Administration (FDA).

Polices & Legislation

FDA to set up abbreviated pathway for complex products posted 21/10/2016

As part of the Generic Drug User Fee Amendments (GDUFA II) reauthorization recently agreed with industry [1], the US Food and...

Reports

Equivalence of complex drug products posted 21/04/2017

Complex drug products and their generic (or follow-on) versions was the subject discussed at the New York Academy of Sciences...